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BSD MED - Gastroenterology - Clinical Research Staff

About the Department

The Section of Gastroenterology, Hepatology at The University of Chicago is consistently ranked among the best specialty nationally by U.S News and World Report. With nearly 30 specialists on staff, our program plays a leading role in the understanding of digestive diseases and in developing innovative and successful treatments for patients. Since forming the nation\'s first full-time department of gastroenterology in 1927, our physicians have continually improved treatments for digestive tract and related disorders by combining medical research, education, and patient care at the highest level.

Job Summary

The Senior Clinical Research Coordinator (Sr. CRC) is a specialized researcher partnering with the clinical Principal Investigator (PI) and under the direction of the Clinical Research Manager within the Section of Gastroenterology in the Department of Medicine. While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the Sr. CRC oversees, facilitates and coordinates the daily activities of complex clinical trials and plays a critical role in the conduct of the studies to ensure compliance with federal and institutional regulations.

Responsibilities

• Leads within the department/unit through improving clinical research practice and serves as a resource to others.
• Works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical studies.
• Assists with or plans and implements the clinical study\'s goals and objectives; organizes patient enrollment planning; conducts quality assurance activities, compiles and analyzes data.
• Acts as a liaison with medical staff, University departments, ancillary departments and/or satellite facilities.
• Serves as a resource person or acts as a consultant within area of clinical expertise.
• Acts as a leader within the department/unit through improving clinical research practice and serving as a resource.
• Maintains working knowledge of current protocols, and internal SOPs.
• Accountable for high standards of clinical research practice and assists in the development of accountability in others.
• Develops and implements procedures, maintains records, tracks progress, and conducts quality assurance on data collected.
• Oversees and participates in the coordination and conduct of complex clinical research studies and ensures compliance with federal and institutional regulations.
• Prepares, submits, and assists Investigators with multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms).
• Provides Investigators with guidance regarding protocol requirements.
• Maintains regulatory documentation.
• Assists other research personnel with reports to regulatory agencies, such as the IRB, FDA and Data and Safety Review Committee.
• Prepares for and assists with audits, inspections, and monitoring visits from regulatory agencies or sponsors.
• Provides direct supervision of other CRC staff (i.e. hiring/firing, performance evaluations, disciplinary actions, approve time off, etc.), or assist.
• Attends continuing education and training opportunities relevant to job duties.
• Solves complex problems relating to data management and the analysis of large administrative datasets. Works independently to develop, manage, and report on key data and ensures timeliness of data and re orting submissions from multiple investigators.
• Acts as a resource on the basics of clinical research and related aspects of clinical study for colleagues with less experience. Prepares and evaluates writing protocols, IRB submissions, grant applications, manuscripts, reports, and dissemination tools.
• Performs other related work as needed.

Minimum Qualifications

Education:

Minimum requirements include a college or university degree in related field.

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Work Experience:

Minimum requirements include knowledge and skills developed through 5-7 years of work experience in a related job discipline.

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Certifications:

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Preferred Qualifications

Experience:

• Clinical research experience coordinating multiple and variety of studies (e.g., investigator initiated; industry sponsored; multi-site trials).

Preferred Competencies

Aware of safety hazards and take appropriate precautions.

Communicate in writing.

Communicate orally.

Comprehend technical documents.

Condense complicated issues t